# FDA recall Z-2135-2020

> **MOTEK MEDICAL B.V.** · Class II · device recall initiated 2019-07-29.

## Product

Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.

## Reason for recall

The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.

## Distribution

Worldwide distribution - US Nationwide distributions including in the states of AZ, CA, FL, KY, MA, MI, NJ, NY, NC, and OH. The countries of Argentina, Austria, Belgium, China, Curacao, Czech Republic,  Denmark, Ecuador, Egypt,  Finland, France, Germany, Japan, Mexico, Netherlands, Russia, South Korea, Spain,  Switzerland, and United Arab Emirates.

## Key facts

- **Recall number:** Z-2135-2020
- **Recalling firm:** MOTEK MEDICAL B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-29
- **Report date:** 2020-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Amsterdam, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2135-2020

## Citation

> AI Analytics. FDA recall Z-2135-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2135-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*